Home / 510(k) Clearances / K910742

510(k) K910742

MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER by Graphic Controls Corp. — Product Code KXO

K910742 is an FDA 510(k) premarket notification submitted by Graphic Controls Corp. for the device "MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER". The FDA issued a decision of Substantially Equivalent on January 14, 1992. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Graphic Controls Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1992
Date Received
February 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Graphic Controls Corp.

  • K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE (November 13, 1998)
  • K983287 — MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (November 5, 1998)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE (May 12, 1998)
  • K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (August 27, 1997)
  • K964387 — POINT OF USE II SHARPS-A-GATOR (March 27, 1997)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE (November 19, 1996)
  • K963038 — MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE (November 15, 1996)
  • K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30 (October 28, 1996)

Other clearances for product code KXO

  • K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUP (July 8, 1999)
  • K982565 — EASY TRANS TIP (September 22, 1998)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K961290 — IUP - TIP TRANS, IUP - PROXI TRANS (October 15, 1996)
  • K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER (July 24, 1995)
  • K950708 — LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (May 25, 1995)
  • K922323 — MX4042/MC4044 SERIES SIMULCATH(TM) (June 14, 1994)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K905563 — INTRAN PLUS (June 19, 1991)

FDA data resources